About

Our Journey with Follow-on Biologics

Biosimilars, biobetters, and bioparallels have become a major area of expertise, service, and thought leadership for Matrix45 – meriting its own website.

Going back also to predecessor companies, Ivo Abraham and Karen MacDonald, co-founders and principals of Matrix45, have worked globally on biologics since 1998, designing many innovative and highly cited studies in such areas as oncology, hematology, nephrology, critical care, surgery, transplantation, immunology, dermatology, virology and infectious disease, respiratory disease, to name the major.

Innovation and Evolution

In 2009, as the exclusivity period of first-generation biologics expired in Europe,we were asked to lend our expertise to the launch of the first three biosimilars approved in Europe (Zarzio®, Binocrit®, Omnitrope®). This has since evolved globally to include North and South America, the Middle East, East Asia, and South Asia.

In 2015, we supported the US launch of the first biosimilar in the US (Zarxio®).

In 2021, we supported the US launch of the first interchangeable biosimilar in the US (Semglee®)

In 2023, we supported the US launch of, Remsima SC®, the first biobetter of a biosimilar – an improved biosimilar.

We coined the term bioparallel in 2021 to refer to biologics that are later-in-class entrants competing mainly on price. In 2023, we supported the US launch of Loqtorzi®, the first FDA approved Chinese PD-1 inhibitor bioparallel.

Along the way, we innovated how to demonstrate the clinical, economic, and societal benefit of follow-on biologics

Global Impact and Vision

We published the first peer-reviewed papers on the economics of biosimilars. We have continued to do so – broadening scope and expanding global reach in the process.

We think and act globally. We have argued that the rapid growth in and supply of follow-on biologics may very well exceed the needs of the 1 billion people in the high-income countries of the world. Follow-on biologics, including those referencing medicines on the WHO Model Lists of Essential Medicines, may bring access to biologics to the other 7 billion people of the world.

We have worked on follow-on biologics of the following 9 medicines on the 2023 WHO Model List of Essential Medicines: epoetin, filgrastim, pegfilgrastim, insulin glargine, rituximab, infliximab, bevacizumab, trastuzumab, and adalimumab.

Why Are We Committed to Follow-on Biologics?

• They lower the cost of treatment.
• They yield cost-efficiencies.
• They enable expanded access to (biologic) therapy – on a budget-neutral basis.
• They improve patient equity.
• Everywhere in the world.

Unlike small-molecule generics, the follow-on biologics space is complex, full of opportunities, yet with challenges to overcome, none of them insurmountable.

More information on Matrix45 and its principals may be found here.